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Company: A10 Clinical Solutions Inc
Contact Name: Neha

Job Details: Physician Date: Jan 03 2018

Job Reference: 242001
Job Category: Health Care Jobs [ View All Health Care Jobs Jobs ]
Company Type Employer
Employment type: Contract
Degree: Masters
Experience: 3 years
Location: Hopewell, New Jersey, 08525
Job Skills: Safety, Argus, ICSRs
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Job Description

Medical Review Safety Physician
Department Title and Description
R&D Global Regulatory and Safety Services -
Global Pharmacovigilance and Epidemiology (GPV&E)
Key Responsibilities and Major Duties
Medical Review: The Medical Review Safety Physician provides high quality medical review of ICSRs including adverse event and suspect product selection, determination of seriousness, labeling and causality assessment, requesting additional information, and providing a Company medical evaluation comment. The Medical Review Safety Physician reviews daily line listing reports for quality monitoring purposes; identifies errors & inconsistencies, and initiate case correction.
Compliance: Ensures complete and timely reporting of ICSRs to regulatory authorities globally. Demonstrates ability to apply BMS operating philosophy and operate within company policies and procedures and appropriate regulations.
Collaboration: Partner with GPVE personnel from other functions (AE processors, safety scientists and safety assessment physicians) in evaluating the safety profile of BMS compounds.
Development/Processes: Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Is an active, high energy proponent of the company’s commitment to public health. Influences and impacts others through clear reasoned argument, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives. Represents GPVE within areas of responsibility and competence and experience. Ensures that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and safety in accordance with company cost effectiveness goals.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

List of minimum requirements
• Degree/Certification/Licensure Education Required: MD or Equivalent. Board certification and medical specialty preferred.
• Experience – Responsibility and minimum number of years Minimum 2-4 years in clinical practice or relevant setting.
Minimum 1-3 years in pharmaceutical industry (pharmacovigilance preferred).
• Competencies – knowledge, skills, abilities, other Knowledgeable and skilled in medicine and pharmaceutical product safety.
Experience applying medical knowledge to the interpretation of individual case review.
Experience with reporting of individual adverse events.
Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers.
Ability think clearly and decisively and present independent, reasoned solutions to identified safety issues, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives.
Demonstrated creative problem solving skills that enact change and drive continuous improvement.
Excellent oral, and written English skills; excellent communication, interpersonal and time management skills
Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment.
Ability to build and manage inter-relationships by motivating and inspiring others.
Ability to operate with minimal direction.
Experience in Argus safety database is preferred.

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